Urine collection device

ABSTRACT

A urine collection device comprises a collector to collect urine voided by a user, first and second outlets to allow urine to drain from the device, the first outlet being adapted for connection to a receptacle for a forestream urine sample, and the second outlet comprising an overflow outlet. A diverter device is provided having first and second operative states, such that in a first state the diverter device allows urine to flow through the first outlet to the receptacle for collection of the forestream sample, and in a second state the diverter device prevents flow to the first outlet and allows flow to the overflow outlet, the diverter device being unable to return from the second state to the first state. The collector is a funnel whose open lower end forms one of the outlets, and also has the other outlet in the funnel wall.

This invention relates to a device to assist in the collection of urinefrom a patient. In particular, the device is designed to collect initialurine flow, known as a forestream sample.

Analysis of urine is used as a diagnostic tool for detecting a widerange of conditions and disease. The urine can be analysed forparticular chemicals that are indicative of infections or whose levelsmay indicate diseases, including cancer. Different conditions ordiseases arc detected by analysis of different parts of urine flow. Theinitial flow or forestream may have a higher concentration of bacteriaor substances largely resident in the urethra, than the midstream flow.These might include infective organisms of urethritis such as gonococcusor chlamydia, or prostatic secretions. The forestream will not be asrepresentative of the general composition of the urine, for example indetecting overall urinary protein or sugar levels, or general urinarytract infections. For these a midstream sample is preferred.

The patient is typically required to provide a urine sample in a samplebottle. Standard sample bottles are relatively small and have a narrowneck, making it difficult for the patient to deliver a sample accuratelyinto the bottle. The part of the flow that is not required must also bedisposed of, and it can be difficult to do this cleanly, especially forfemale patients.

Devices are known for assisting collection of a forestream sample. U.S.Pat. No. 7,547,298 shows a device having a funnel for collecting urine,an outlet connected through a valve to a sample bottle, and an overflowoutlet. Initial flow is directed through the valve into the bottle, fromwhich air leaves through a vent tube. When the urine level reaches thevent, no further flow into the bottle is possible, and the level ofurine in the device rises to allow further flow to pass out through theoverflow outlet. On completion of urination, the valve provides afurther path to the overflow outlet to release a trapped volume. Anothersmall volume is released into the bottle as it is detached. This deviceis efficient at capturing the forestream, but it has a complexconstruction, due to the valve.

A simpler construction is shown in WO 2005/107602. This has a funnelwith a tube at its base leading to two outlets. A sample bottle isattached to the first outlet, while the second is an overflow outlet. Aflow barrier is placed in the tube at the first outlet, to guide theinitial flow preferentially to the bottle, and to allow air to leave thebottle. Once the bottle is full the urine passes to the overflow outlet.A valve may seal the forestream sample in the bottle. However, onremoval of the bottle a trapped volume of urine in the first outlet willbe released, which will be messy. The flow barrier provides a simpleconstruction but its correct operation depends on the flow rate, and itcannot consistently ensure only or all of the forestream is guided tothe bottle.

According to the present invention, we provide a urine collection devicecomprising a collector to collect urine voided by a user, first andsecond outlets to allow urine to drain from the device, the first outletbeing adapted for connection to a receptacle for a urine sample, and thesecond outlet comprising an overflow outlet, and a diverter devicehaving first and second operative states, such that in a first state thediverter device allows urine to flow through the first outlet to thereceptacle for collection of a forestream sample, and in a second statethe diverter device prevents flow to the first outlet and allows flow tothe overflow outlet, the diverter device being unable to return from thesecond state to the first state.

Providing the diverter device with two operative states means that itwill ensure efficient operation, both of collection of the forestreamsample and the diversion of the remaining flow to the overflow outlet.As the diverter device does not return from the second state to thefirst it does not need to be a valve, and can thus have a simpleconstruction, making the device overall of simple construction.

The device is designed to be used in a substantially vertical position,and so will be described in that orientation with the terms top, base,upper and lower referring to a vertical orientation.

Conveniently the collector comprises a funnel member, wider at the topfor ease of use, and narrower at the base. The funnel member has afunnel wall comprising a substantially frusto-conical top portion, and abase portion. The lower end of the base portion is open. The baseportion may be substantially cylindrical. One of the first and secondoutlets is provided by the open end of the base portion, and the otheris provided in the funnel wall. The device preferably has only twooutlets.

In one embodiment the first outlet is provided in the base portion ofthe funnel member, and the second, overflow outlet is provided in thefunnel wall. The diverter device comprises a plug accommodated in thebase portion, the plug in the first state allowing flow to the firstoutlet, and expanding on contact with liquid into the second state toprevent further flow to the first outlet and allow flow to the overflowoutlet. The plug provides a particularly simple and effectiveconstruction of diverter device.

The base portion of the funnel member is adapted for connection of thereceptacle, so that this is substantially vertical in use. Where thereceptacle is a standard sample bottle the base portion may have meansfor engaging the external screw thread found at the top of the bottle,designed for attachment of the bottle cap.

The plug is preferably of an expandable sponge material. It isaccommodated in the base portion of the funnel member. In thisembodiment the base portion is substantially cylindrical. The plug maybe an interference fit in the cylindrical base portion. The plug islocated at its upper end by an abutment in the cylindrical base portion,and at its lower end projects from the cylindrical base portion. Thelower end thus projects into the receptacle when this is attached to thedevice, and leaves a free space at the top of the receptacle when it isremoved, to reduce the risk of spillage.

The second outlet comprises a tube extending from the funnel membersubstantially at right angles to the cylindrical base portion. Thelowest part of the second outlet at its junction with the funnel wall issubstantially level with the upper end of the plug, to ensure that allthe flow which is not collected in the receptacle drains readily fromthe device. The inner end of the tube is angled so that at its highestpart it projects into the funnel to substantially prevent flow throughthe second outlet while the plug is in the first state allowing flow tothe first outlet. The outer end of the tube is shaped to direct the flowaway from the receptacle. This helps to ensure that the outside of thereceptacle is kept clean and dry.

In another embodiment the first outlet is provided in the funnel walland the second, overflow outlet is provided by the open end of the baseportion of the funnel member. The base portion is again substantiallycylindrical. The diverter device comprises a membrane located at theentrance to the second outlet, the membrane in the first state blockingthe entrance to the second outlet and directing the flow to the firstoutlet, and breaking after contact with liquid to allow flow to theoverflow outlet. This also provides a simple and effective constructionof the diverter device.

The membrane is of any suitable material, such as paper sheet or plasticfilm, and is attached to the device by adhesive, for example.

The first outlet comprises a tube extending from the funnel member at anangle. The outer end of the tube is adapted for connection of thereceptacle. The angle of the tube is chosen so that the receptacle isnot horizontal. This ensures that there is free space at the top of thereceptacle when it is removed, thus reducing the risk of spillage. Thesecond outlet is at the lower open end of the base portion, which may beapproximately vertical, or angled the same way as the first outlet.

In either embodiment the device is conveniently made of plasticsmaterial. It has a simple construction, and is easy to use, whilecollecting a forestream sample in an efficient manner.

Embodiments of the invention are illustrated, by way of example only, inthe accompanying drawings, in which:—

FIG. 1 is a longitudinal section through a urine collection device;

FIG. 2 is a side view of the device of FIG. 1;

FIG. 3 is a front view of the device of FIG. 1;

FIG. 4 is a top view of the device of FIG. 1;

FIG. 5 is a longitudinal section through a modified urine collectiondevice; and

FIGS. 6 to 8 are similar to FIGS. 2 to 4, but showing the modifieddevice of FIG. 5.

The urine collection device 1 shown in FIGS. 1 to 4 is for collection ofa forestream sample of urine. The device 1 comprises a collector 2 tocollect urine voided by a user, and first and second outlets 3, 4respectively. The first outlet 3 is adapted for connection of areceptacle 5 for collection of the sample, and the second outlet 4 is anoverflow outlet to deal with the urine flow following the forestream. Adiverter device 6 is provided to direct the urine flow as required. Thediverter device 6 has first and second operative states. In a firststate the diverter device 6 allows urine to flow through the firstoutlet 3 to the receptacle 5 for collection of the forestream sample,and in a second state the diverter device 6 prevents flow to the firstoutlet 3 and allows flow to the second overflow outlet 4. The diverterdevice 6 cannot return to the first state from the second state.

The device 1 will be described in the vertical orientation shown, as itis the normal position of use. Terms such as top, base, upper and lowershould be construed accordingly.

The collector 2 comprises a funnel member 7 having a wall with a widertop portion 8 of substantially frusto-conical shape, narrowing to asubstantially cylindrical base portion 9. The top 8 is angled and shapedfor ease of use. The outer surface has indentations 10 to indicate tothe user how the device 1 is to be held. There is a single indentation10 at the rear of the device 1 for the thumb, and three at the front forthe fingers.

The first and second outlets 3, 4 are provided in the base portion 9which has an open lower end 11. The first outlet is at the lower end 11of the base portion 9. The receptacle 5 is connected to the lower end 11so that it is vertical in use. The receptacle 5 is a standard samplebottle, and the manner of connection will be described below.

The diverter device 6 comprises an expandable plug 12 of spongematerial. The plug 12 is substantially cylindrical and is aninterference fit in the base portion 9. The sponge material is chosen sothat in its first, dry state it allows urine to pass through it. Thematerial expands on contact with liquid and so gradually moves into itssecond state, in which it prevents further urine flow through it. Itwill be appreciated that the plug cannot return from the second state tothe first state. The position of the plug 12 in the base portion 9 isdefined by abutment of its top surface 13 with a rail 14 (best seen inFIG. 4) which extends transversely across the base portion 9. The lowerend 15 of the plug 12 projects below the lower end 11 of the baseportion 9 and into the receptacle 5.

The second outlet 4 comprises a tube 16 extending substantially at rightangles to the base portion 9, so approximately horizontally in use. Thetube 16 projects from the funnel wall above the first outlet 3. As shownbest in FIG. 1, the lowest point 17 of the tube 16 at its junction withthe funnel wall is level with the top of the rail 14, so that it is justabove the top surface 13 of the plug 12. This assists in ensuring thaturine drains easily and fully from the device 1, as there will be notrapped volume of urine on completion of urination.

The inner end 18 of the tube 16 is angled, so that its top surface 19projects slightly into the funnel member 7. This forms a guide surface20 directing urine flow from the top of the funnel member 7 away fromthe overflow outlet 4. The outer end 21 of the tube 16 projects from thefunnel member 7 so that urine leaving the device 1 through the overflowoutlet 4 is directed away from the receptacle 5. The outer edge 22 isalso shaped with a lip to ensure that the overflow urine leaves in astream rather than dribbling back towards the funnel member 7.

The base portion 9 is formed with a lug 23 extending downwardly from thelowest point 17 of the tube 16 to project slightly beyond the lower end11 of the base portion 9. It is best seen in FIGS. 1 and 3. The lug 23provides rigidity for the device 1, and also the connection means 24 forthe receptacle 5. At its lower end 25 the lug 23 has anupwardly-extending rebate 26 and an inwardly-extending projection 27,with which an external screw thread 28 on the receptacle 5 engages toattach the receptacle 5 to the device 1. The upper end 29 of thereceptacle 5 engages the lower end 11 of the base portion 9.

The device is preferably injection-moulded in a suitable plasticsmaterial. It is simple to assemble, as the plug 12 is put in position inthe base portion 9. The assembled device 1 (without the receptacle 5)will be packed in suitable protective packaging (not shown) to preventcontamination.

For use, the device 1 is removed from its packaging. A sterilised samplebottle has its top (not shown) removed, and the bottle is then screwedonto the base portion 9 to act as the receptacle 5. The user thenurinates into the top portion 8 of the funnel member 7. The guidesurface 20 ensures that the initial urine flow passes to the firstoutlet 3, through the plug 12 (which is in its first state) and into thereceptacle 5. The plug 12 expands on contact with the urine and assumesits second state, in which further flow through the first outlet 3 isprevented. Urine flow is then directed to the second outlet 4 untilurination is completed. The urine drains fully from the device 1 throughthe second outlet 4. The receptacle 5 can then be unscrewed, leaving theplug 12 in the device 1, so that there is a free space at the top of thereceptacle 5. This reduces the risk of spillage on removal of thereceptacle 5. The receptacle 5 containing the forestream sample can thenbe recapped.

The forestream sample is taken efficiently, with very little or no mess,as the overflow outlet 4 directs the unwanted urine away from thereceptacle 5. The only urine remaining in the device 1 is in the plug12, whose material is chosen so that it does not drip.

FIGS. 5 to 8 show a modification of the urine collection device of FIGS.1 to 4, and corresponding reference numerals have been applied tocorresponding parts.

In FIGS. 5 to 8 the top portion 8 of the funnel member 7 is the same asthat of FIGS. 1 to 4, but the base portion 9 is modified. The firstoutlet 3 is provided in the funnel wall above the second, overflowoutlet 4. The diverter device 6 comprises a membrane 30 extending acrossthe base portion 9 between the two outlets 3, 4. In a first state themembrane 30 prevents flow to the second outlet 4, guiding it to thefirst outlet 3. When wetted, the membrane 30 breaks, assuming its secondstate in which it allows flow to the second outlet 4. Clearly, themembrane cannot return from the second state to the first state.

The first outlet 3 comprises a tube 31 extending from the base portion 9in a direction angled slightly down from the horizontal. The receptacle5 receives the outer end 32 of the tube 31 in a sealing manner.

The second outlet 4 is formed by the open lower end 11 of the baseportion 9, and is of angled outline. It has a vertical portion 33 inline with the funnel member 7, leading to an angled end portion 34. Theend portion 34 is substantially parallel to the tube 31, but is slightlylonger. A projection 35 is provided on the outside of the end portion34, adjacent to the tube 31. The external screw thread on the receptacle5 engages with the projection 35 to attach the receptacle 5 to thedevice 1.

The membrane 30 is accommodated at the top of the vertical portion 33 ofthe overflow outlet 4, substantially in line with the lowest point 36 ofthe tube 31. It may be attached by adhesive or welding, and will be ofany suitable sheet plastics or paper material.

As in the first embodiment, the device 1 is of any suitable plasticsmaterial, and is packaged without the receptacle 5.

For use, it is removed from the packaging and the receptacle 5 attached.The initial urine flow is guided by the membrane 30 through the firstoutlet 3 to the receptacle 5. The flow wets the membrane 30, whichbreaks, so that subsequent flow passes through the overflow outlet 4. Oncompletion of urination the device 1 can be turned so that thereceptacle 5 is closer to the vertical before it is unscrewed from thedevice 1. Because the sample was collected with the receptacle 5 closerto the horizontal, when it is turned there will be free space at the topof the receptacle 5 to reduce the risk of spillage. The receptacle 5 canthen be re-capped and the device disposed of. As with the firstembodiment, the device 1 ensures that a forestream sample is takenefficiently and cleanly, because the urine drains fully from the device1.

In a modification it would be possible for the receptacle 5 to beattached by a push fit onto the first outlet 3 rather than by the screwthread.

What is claimed is:
 1. A urine collection device for collection only ofa forestream sample, comprising a collector to collect urine voided by auser, the collector comprising a body member, having a top portion and abase portion, first and second outlets, the first outlet positioned in aside portion and above the bottom of the body member and configured forconnection to a collection receptacle for a forestream urine sample, andthe second outlet positioned below the first outlet comprising anoverflow outlet, and a membrane extending over the second outlet havingfirst and second operative states, such that in a first state themembrane causes the forestream urine to flow through the first outlet tothe collection receptacle for collection of the forestream sample, andafter being wetted a predetermined time, breaks to assume the secondstate to prevent flow of further urine to the first outlet andcollection receptacle, and causes flow to the overflow outlet, themembrane being unable to return from the second state to the firststate, wherein the first outlet is provided in a wall of the top portionand the second, overflow outlet is provided by the open end of the baseportion of the body member, the membrane breaking after collection ofthe forestream sample and contact with forestream urine to cause furtherurine to allow flow to the second, overflow outlet.
 2. A urinecollection device as claimed in claim 1, in which the collectionreceptacle is mounted with respect to the body member at an angle duringuse, such that free space will be created at the top of the collectionreceptacle after use.
 3. A urine collection device as claimed in claim1, in which the first outlet comprises a tube extending from the bodymember at a small downward angle from a plane of the membrane.
 4. Aurine collection device as claimed in claim 3, in which the outer end ofthe tube is adapted for connection of the collection receptacle.
 5. Aurine collection device as claimed in claim 3, in which the collectionreceptacle receives the outer end of the tube in a sealing manner.
 6. Aurine collection device as claimed in claim 1, in which the secondoutlet is at the lower open end of the base portion, which issubstantially cylindrical.
 7. A urine collection device as claimed inclaim 3, in which the second outlet has a vertical portion in line withthe body member, leading to an angled end portion.
 8. A urine collectiondevice as claimed in claim 7, in which the angled end portion issubstantially parallel to the tube, but is slightly longer.
 9. A urinecollection device as claimed in claim 7, in which a projection isprovided on the outside of the end portion, adjacent to the receptaclewhen attached to the first outlet, to attach the receptacle to the firstoutlet.
 10. A urine collection device as claimed in claim 7, in whichthe membrane is accommodated at the top of the vertical portion of thesecond outlet, substantially in line with a lowest point of the tube.11. A urine collection device for collection only of a forestreamsample, comprising a collector to collect urine voided by a user, thecollector comprising a body member, having a top portion and a baseportion, first and second outlets, the first outlet positioned in a sideportion and above the bottom of the body member and configured forconnection to a collection receptacle for a forestream urine sample, anda membrane extending over the second outlet having first and secondoperative states, where in the first state the membrane directs theforestream urine to flow through the first outlet to the collectionreceptacle for collection of the forestream sample, and breaks to assumethe second state from exposure to urine after a time to collect theforesteam sample to direct the flow of further urine to the secondoutlet, wherein the first outlet is provided in a wall of the topportion and the second outlet is provided by the open end of the baseportion of the body member.
 12. A urine collection device as claimed inclaim 11, in which the collection receptacle is mounted with respect tothe body member at an angle during use, such that free space will becreated at the top of the collection receptacle after use.
 13. A urinecollection device as claimed in claim 11, in which the first outletcomprises a tube extending from the body member at a small downwardangle from a plane of the membrane.
 14. A urine collection device asclaimed in claim 13, in which the outer end of the tube is adapted forconnection of the collection receptacle.
 15. A urine collection deviceas claimed in claim 13, in which the collection receptacle receives theouter end of the tube in a sealing manner.
 16. A urine collection deviceas claimed in claim 13, in which the second outlet has a verticalportion in line with the body member, leading to an angled end portion.17. A urine collection device as claimed in claim 13, in which theangled end portion is substantially parallel to the tube, but isslightly longer.
 18. A urine collection device as claimed in claim 13,in which the membrane is accommodated at the top of the vertical portionof the second outlet, substantially in line with a lowest point of thetube.
 19. A urine collection device as claimed in claim 11, in which aprojection is provided on the outside of the end portion, adjacent tothe receptacle when attached to the first outlet.
 20. A urine collectiondevice as claimed in claim 19, wherein the projection engages anexternal screw thread on the receptacle.